Comments on Pallimed: A Hospice and Palliative Medicine Blog: Onsolis and FDA Opioid REMS: Is this the future of...

These idiots! If a pizza delivery man can't av...

2010-02-26T22:11:45.706-06:00

These idiots! If a pizza delivery man can't avoid getting robbed, God only knows what will happen to an opiate delivery person.

Chuck

These idiots! If a pizza delivery man can't av...

2010-02-26T22:11:12.299-06:00

These idiots! If a pizza delivery man can't avoid getting robbed, God only knows what will happen to an opiate delivery person.

Chuck

Gail - thanks for your/AAHPMs advocacy on this; an...

2009-10-01T19:55:35.835-05:00

Gail - thanks for your/AAHPMs advocacy on this; and the acetaminophen 'ban percocet' fiasco.

Just what we need--more barriers to symptom relief...

2009-10-01T06:37:03.058-05:00

Just what we need--more barriers to symptom relief for our patients. I have to spend way too much time trying to convince patients to actually take the "dangerous" pain medications that will control their pain or dyspnea as it is. Can you imagine their reactions to things being delivered via special courier? Fortunately, I can't imagine having to prescribe Onsolis, but the extended release hydromorphone would be a benefit to some of our patients...(sigh)

AAHPM has been following the REMS activity in DC a...

2009-10-01T04:07:13.733-05:00

AAHPM has been following the REMS activity in DC and sent a representative to some of the meetings. As I understand it, the cost of the REMS is built into the drug pricing, making already expensive new medications even pricier. Combined with the red tape for prescribing, this makes access a grave concern!

The government, ie, FDA, is trying to control not ...

2009-09-30T19:12:55.089-05:00

The government, ie, FDA, is trying to control not only the science of medicine, but now the art. These drugs are going to be prohibitively expensive to purchase monetarily speaking and prohibitively expensive in time and energy to even prescribe. Health care professionals already spend and enormous amount of time on charting, dictating and going to required meetings. All these take TIME away from the patient, and that is a shame!!

The bottom line is that these drugs will be so expensive, that no hospital will have it on formulary, Medicaide and Medicare will approve in 2020 and the private companies will follow.

...and I thought death panels were scary...

2009-09-30T13:13:43.562-05:00

...and I thought death panels were scary...

Ummm... lots of good points brought up in the abov...

2009-09-28T22:04:28.941-05:00

Ummm... lots of good points brought up in the above comments. Palladone was pulled because it dumped excess opioid when the tablet/capsule (don't remember which) was exposed to alcohol. That hasn't come up as a problem with Exalgo. There is some good history on all of this in the background documents from the FDA and the manufacturer -- links to these are in my webpost at http://bit.ly/90gc6 (URLs are too long to include here). As for the education issue, it's not clear who will be developing those materials but they will probably go through FDA-approval to be sure that marketing hype in avoided. As for the Onsolis REMS, one of the complaints from the field was that in-patient facilities, including hospice, were being excluded (that is, they could not have the drug delivered to them). It's still early in the game but the whole REMS initiative is showing all the signs of becoming the nightmare we were afraid it would be. -- SBL

And by 'Steve' I mean 'Stewart' (a...

2009-09-28T21:26:10.918-05:00

And by 'Steve' I mean 'Stewart' (as in Leavitt).

CTS: I read the REMS on Onsolis a while back, and...

2009-09-28T21:15:26.276-05:00

CTS: I read the REMS on Onsolis a while back, and while I haven't gone back to it I think it specifies that in fact the drug can't be prescribed inpatient.
I have no plan on doing this for Onsolis, and remain underwhelmed by the clinical need for transbuccal fentanyl (it's there, happy it's available, but really rarely needed); but if ER hydromorphone becomes available will likely want to do that. Thanks Steve for the heads up on it - look forward to your post CTS.

SB Leavitt, Thanks for the tip on Exalgo. I may...

2009-09-28T20:57:23.754-05:00

SB Leavitt,

Thanks for the tip on Exalgo. I may make that into a post here later on this week. Interesting given Palladone was pulled from the market. Do you know of a resource which given when these meds were FDA approved/introduced to the US market and/or removed? That would be an interesting database. Thanks for the link for more info.

LCSW and Eric W.,

The FDA FAQ talks about not being a problem for rural areas given the couriers could go anywhere. But really the price of getting a courier to send out scripts has to be rolled into the drug price. So time and money become barriers there.

Also my wife (Mrs. Pallimed) brought up a great point, the people doing the prescriber education for the REMS is the drug company. No conflict of interest there in telling you how great their medicine is. She also asked me about inpatient prescribing which I would presume not be a problem, but I cannot imagine any hospital P&T committee wanting to get this approved.

Who pays for the FOCUS program, the couriers, and ...

2009-09-28T11:17:30.590-05:00

Who pays for the FOCUS program, the couriers, and the counseling call. Will it be priced in the medication cost or will the patient need to pay for this?

I don't think one can convince me that this wi...

2009-09-28T10:39:53.536-05:00

I don't think one can convince me that this will not limit access and create unneccessary barriers. I would venture a guess that no one sat on this committee that lives in rural areas where patients often can not even get to a hospital for pain management. I do think diversion is something that needs to be addressed but I have little hope that REMS will help with this. The list of meds under consideration for REMS include meds we use on a daily basis in hospice care. We have medicaiton to the patient's home in three to five hours. Often times when the patient is admitted to services they are already in a pain crisis...where is the data that suggests that this would help with diversion?

IT GETS WORSE. On September 23, 2009 an FDA expert...

2009-09-28T09:24:01.525-05:00

IT GETS WORSE. On September 23, 2009 an FDA expert panel endorsed manufacturer plans to introduce Exalgo™, a new extended-release formulation of hydromorphone. Final FDA approval of the analgesic, possibly in November, would include a REMS (Risk Evaluation and Mitigation Strategy) program that may portend the future of regulatory burdens on opioids and have serious negative consequences for both healthcare providers and patients. The egregious Onsolis REMS was supposed to be an exception, but the Exalgo REMS has many of the same elements and this may be the prototype of what lies ahead for all extended-release and long-acting opioids. I’ve written more on this at: http://bit.ly/90gc6 -- SBL.