Wednesday, April 1, 2009
FDA Shocks Hospice World: No More Roxanol
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Ha ha. Pretty funny. Oh wait, there is a link. To the REAL FDA site. Oh boy. Not a joke.
14 medications are included in the decree to stop production including different concentrations/strengths of morphine, oxycodone and hydromorphone. This is part of a larger initiative launched by the FDA in the summer of 2006 to crack down on production of non-FDA approved meds. The reason: "It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality." Followed by "Today's warning letters are another demonstration of our commitment to remove illegal, unapproved drugs from the market."
What is the impact? Let's take morphine as an example: Instead of morphine 20mg/ml the only concentrations available will be 10mg/5ml and 20mg/5ml.
Giving a dying patient with dysphagia 5ml instead of 1ml to get them 20mg of morphine will make a big difference in oropharyngeal secretions. So then we may see an increase in distress from families, patients, and staff about 'pooling secretions' leading to more scopolamine patches and atropine which are unfortunately ineffective at doing anything with accumulating secretions from exogenous sources, like medications.
Also now with this hitting the news, families and patients are going to have a lot more doubt about hospice using these 'unapproved' and 'illegal' medications that have been the standard of care in hospice.
What else may happen? Hospices move away from oral route and begin using more subcutaneous opioids to avoid the secretion issue above. This may lead to increased costs in training families to administer SC meds, which may lead to an increase in medication errors, or avoidance in giving medications because of families discomfort/barriers to giving SC meds. If this happens it will also result in a large increase in the amount of IV/SC controlled substances in the community, which could be a more attractive target for diversion without new policies to secure the medications.
Also, nurses and physicians may have more errors in calculation of opioid conversions if there is not a clear communication about what concentration one is working with. The potential to over or underdose by a factor of 5 could result in a series of unfortunate events.
Hospice agencies will spend a whole lot of time re-educating staff about these changes as well which could be a significant diversion of valuable time and resources.
That sounds scary. Can't you think of anything good from this? OK, enough hyperbole. Maybe this will bring more attention to the problem of iatrogenic contributions to secretions and the use of SC meds will actually result in more peaceful deaths without as much 'gurgling' form sublingual morphine that is never actually cleared.
Maybe the role of opioid conversions will be given the respect and attention it requires by both nurses and physicians, resulting in discussions of medications only in terms of mg not ml. (WARNING - Sinclair Pet Peeve! - WARNING) Health care professionals talking to other health care professionals should ALWAYS talk in terms of the dose prescribed (i.e. milligrams) not milliliters, in order to avoid any miscommunication. When instructing, it is often easier to 'translate' to terms of volume. I have no problem with that.
Maybe we will get more funding for palliative medicine research to look at the effectiveness of our anecdotally effective but minimally evidence based standards of care. A long term goal at best.
How can this be solved? Sure maybe your pharmacy may compound the 20mg/ml, but would you risk the liability if the FDA is committed "to remove illegal, unapproved drugs from the market?" I probably wouldn't unless in special circumstances as the clinical situation warrants.
I bet at least one pharmaceutical company will be racing to corner the market and seek FDA approval for morphine 20mg/m, but if they do a second company can file an Abbreviated New Drug Application and ride to coattails of the first company without doing the work (a me-too application). Will this paralyze the race? I don't know.
And if a company does put forth the effort will it result in two major changes: one where morphine 20mg/ml is unavailable and then is available a few months later thereby compounding the chances for miscommunication about concentrations used in clinical care.
Well we have 90 days at least to figure this one out. Does anyone in our field know if the FDA even discussed this with the major prescribers (hospices) to see if a compromise or degree of impact study was considered?
PET PEEVE ALERT #2 The FDA called these medicines 'narcotics' all over the press release instead of the more accurate term 'opioids.' I did not see marijuana or cocaine (both narcotics per the FDA/DEA) on the lists. Call them opioids, that is the correct class of medications.
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21 Responses to “FDA Shocks Hospice World: No More Roxanol”
April 02, 2009
I've just left a comment on the FDA website, and I encourage others to do the same. Using the link provided in this item, navigate to the FDA home page, select Contact FDA, and let them know how you feel.
Robert A. Fried, M.D.
Medical Director, Palliative Care & Hospice Services
NorthShore University HealthSystem
Evanston, Illinois
April 02, 2009
In our hospital, we have moved to have our "standard" morhpine and oxycodone solutions be the less concentrated versions because of the frequency with which we use low doses of morphine and oxycodone (e.g. 2.5mg or 5 mg) with some of our fraily elderly patients. Having only 20mg/ml available on formulary (which is how it has been at my institution) has created the potential for (and actual) medical errors with nurses not realizing what a very small volume is required to give a dose of 2.5mg, for instance.
HOWEVER, I certainly do not support the removal of these preparations from the market as they are clearly very useful in patients at the end of life with limited ability to swallow larger volumes and for those patients requiring high doses for breakthrough pain. This is shocking!
April 02, 2009
I completely agree with your pet peeves. Not only has the ml vs mg led to miscommunication amongst staff, family has the same confusion. "I gave them 1 of the ativan" 1mg? 1ml? I've actually had a situation where the family was accidently overdosing a patient because some staff were talking in mgs and some mls.
I've also seen the FDA use the term "narcotic" related to other opioids.
April 02, 2009
The FDA site also says, "The FDA has determined that removal of the unapproved narcotic products will not create a shortage for consumers." We recently experienced a shortage of narcotics overall based on manufacturing issues. I am SOO reassured by the government's statements...aren't you? (=sarcasm, in case you weren't sure).
I think it is a tragedy that continually gets repeated in medicine: process trumps care. You can't do this because of x, even if it means patients will not have their issues dealt with. Guilty parties are not limited to the government.
Re: Pet Peeves, you could not be more on target with this. I have seen the same thing Dr. Wollesen has, with unfortunate effects, and sometimes even from well trained Hospice nurses. As in the original post, maybe something good will in fact come of this.
April 02, 2009
Holy crap! Our pharmacy hasn't communicated any of this to the hospice team...yet. Just a couple of weeks ago we had a situation where the RN at an assisted-living facility didn't want to give our patient SC meds to keep his terminal seizures under control (she thought it would hurt him to give it to him SC! More than the seizures were hurting him?) Luckily we were able to get a compounding pharmacy involved to change some of the meds into suppositories but he still needed sublingual morphine and ativan. I can't even imagine the long-term effects if/when this happens.
April 02, 2009
Nearly every day I am calling one pharmacy or another to see what opioids I can prescibe for my outpatients because of shortages of oxycodone, morphine, and hydromorphone. Yesterday I wrote 5 scripts for 2 drugs (one long-acting, one short-acting) in various mix & match combinations of doses in order to get the patient the analgesics she needs for the next two weeks. I also had to get pre-authorizations for a dose increase on one (it wasn't really a dose increase--just looked like it because of the mix & match) and a drug change on the other because of the oxycodone shortage. It took the pharmacist and I an hour on the phone to work it all out.
I still haven't seen a reasonable explanation of why we have an oxycodone shortage that is now into its 3rd month.
A couple of years ago the DEA stopped allowing the use of 40 mg tabs of methadone for pain management and claimed there would be no impact on clinical care of patients. Oh, really?
The opioids that are being pulled because they haven't been approved have been on the market legally for years. The FDA statement is a bit disingenous. These products were approved by grandfathering years ago. They didn't go through the usual approval process, but they still need to be manufactured to FDA standards. They aren't being produced in someone's basement lab and they aren't unknown entities.
I generally don't pay attention to conspiracy theories, but I'm beginning to formulate one of my own.
Tom
April 02, 2009
I think it's time for another demonstration in front of the FDA!! I was there in the 70's demonstrating against use of DES and in again in the 90's in favor of speedy drug approval for HIV antivirals. Let's go!!!
April 02, 2009
Thanks for giving the heads up on this. Christian. Haven't heard from the national hospice pharmacy that we work with about what to expect. Will be leaving a comment with the FDA as well.
April 02, 2009
Thanks everyone for the tremendous response. I have not been able to answer all of these individually but it is obvious the sense of frustration and outrage is there.
Here are excerpts from emails I got about the article:
To whom can we write to protest this possible action. It is truly a disservice to those patients who endure pain at end of life.
----
this is appalling! Speaking both as a hospice nurse and as a daughter having attended both my dad and my step-dad's final weeks, i would be hamstrung if we did not have the concentrated Roxanol. this certainly will contribute to client discomfort. The important question now is, what can we DO about this distressing news story? Who can we contact, or is this already a done deal?
I think a letter writing campaign is a valid approach, but it may be best organized through our larger membership organizations if they hear it important to all of you.
NHPCO is going to Capitol Hill on April 22nd so if you want it to be addressed, make it part of their agenda and forward the link to this post and comments
http://www.pallimed.org/2009/03/fda-shocks-hospice-world-no-more.html
I will talk to some leaders within AAHPM for some guidance.
April 03, 2009
I do believe that medications need to be regulated since there are risks associated with all medications (OTC and RX). As healthcare professionals, we should not justify the use of any medication or other treatments with the lack of information (ie, "nothing has ever happened...yet"). As for communication to healthcare providers, it is the responsibility of every licensed professional to keep current with news and regulations. There are many organizations and news feeds that give accurate, timely information. Not doing so can ultimately harm patients.
April 03, 2009
Keep us updated Christian about advocacy about this. There are clearly safety issues with these formulations but out right banning them seems extreme. Are the safety issues any worse than with other drugs?
Anyway: April Fools' - I announced to my team (name dropping Christian as he's a board member now) that AAHPM had decided to change its name to American Academy of Thanatology and Death Medicine. Good times were had by all.
I had thought about composing a couple 4/1 posts: 'Codeine superior to Morphine in large RCT of cancer pain.' 'South Carolina removes hospice benefit from public insurance programs.' Oops, that last one was actually being tossed around a while back. Reality continues to be zanier than my imagination....
April 05, 2009
AAHPM/NHPCO and others are working on a coordinated response likely to come early this week is what I have heard.
Good April Fools jokes Drew.
April 07, 2009
I was on a conference call with a branch of the FDA this afternoon. The FDA representatives which led the Q&A seemed quite surprised that the difference in volume we will soon be forced to deal with actually matter! They just don't get it! I truly don't believe this action was well thought out nor researched. I too have a few "theories" wandering thru my mind on this one. Especially since the FDA reps stated that Oxy-fast was not an "approved" medication, yet they decided to leave it be for now and just focus on the Roxanol 20mg/ml... hmmm
April 07, 2009
I would encourage everyone to contact members of the congressional committees that have FDA oversite on this mind-boggling issue:
House: Energy and Commerce
Chair, Rep. Henry Waxman (D-CA)
http://energycommerce.house.gov/
Senate: Health, Education, Labor and Pensions
Chair, Sen. Edward Kennedy (D-MA)
http://help.senate.gov/
The committees have web sites listing all committee members--any advocacy efforts are best aimed here. We all need to weigh in on this.
April 09, 2009
Although a little late, I blogged about this subject today.
Also, as a pharmacist, let me tell you that I would have absolutely no qualms with compounding a 20mg/ml morphine solution. Compounding is intended to provide medications in doses or dosage forms that aren't commercially available . . . and that's exactly what a compounded 20mg/ml solution would do.
April 10, 2009
I am the medical director of a HPC unit at a VA facility. We have had daily emails from our pharmacy notifying us of shortages of opiates ( for the last 2-3 months now). Lack of 20mg/ml morphine, oxycodone, hydromorphone, hydrocodone/acetamenophen has had a direct impact on patient care. We have indeed used more subctaneous administration of meds often earlier than I would normally have used it. Though this has often been fine for the patients, it has been very stressful for staff as we did not have enough RNs trained ( certified through the VA) to provide this care. Through this ordeal I have gotten approval to use ketamine at this facility( something that had been difficult in the recent past) so I guess I had at least one positive outcome. However, as Tom Quinn and others have raised suspicion with regard to conspiracy, how long will it be until a drug such as ketamine comes under scrutiny? It sure is cheap! and one of many that the HPC community uses off label. I am baffled by the FDA's actions.
I plan on contacting Senator Kennedy ( hoping he doesn't need any HPC services anytime soon) and Congressman Waxman to express my concern.
April 11, 2009
As a patient who takes MSIR 20 Mg/ml on a daily basis, removal of this pain killer to deal w/a lifelong chronic pain condition will only mean eventually I'll put a gun in my mouth. For well over
40 years I have dealt w/ chronic pain. To many, its no big deal & they say there are alternatives.
For me, its a daily fight to deal w/ what can become excruciating pain & the alternatives have all proven to be sorely inadequate. After years of experimental treatments & no success, all I asked was to be able to be reasonably comfortable so I could have a life.
All will have cures for me, as many have all these years. Yet all I get is more pain, more hassles, more "I" know best, & finally some who truthfully admit, I/we have no idea what causes your lifelong chronic cluster headaches.
This appears to me to be another example of do gooderism intentions that bring suffering to a few, so who cares. After all, only those making the rules know better than anyone else. The rest & especially the patients are simply, well, stupid!
April 11, 2009
Anon: not to worsen your day but I actually think the REMS program that is being batted around might be even worse news for patients in your position (those with chronic, non-cancer pain who benefit from opioids long-term): depending on how draconian it is/how high the barriers are put up to discourage docs from prescribing opioids outside of acute pain situation I am worried there will be tremendous numbers of patients abandoned by The System (docs/clinicians, insurance cos, health systems, regulatory bodies).
April 11, 2009
I suppose a 9MM would work best!
It makes me angry that I have tolerated this pain all my life, worked hard, played by all the rules, done my level best to be a good citizen, & now it looks like my own government wants to tell me I cannot have pain meds, because
"they" think they are not necessary
& after all, my Dr. "must" be feeding a habit. Sure, I've gone nearly insane from days, even weeks & months & years of pain, from a lifelong chronic pain condition that dozens of Dr's have not been able to figure out, just so I can have drugs!
I wish I could have some of these guys live just a month in the pain I tolerate. I ask for no special treatment, just to be able to function & have a life! Add osteo-necrosis to the list of maladies & what they are telling me is "I" am not worth their trouble!
Doesn't a lifetime of documented medical treatment mean anything when these decisions are being made by people who know nothing of my medical situation?
April 12, 2009
Anon 4/11,
I presume the two posts are from the same person. I would encourage you to use your experience with frustration at the medical system to help change and construct a better system.
I would encourage you to check out the War on Doctors/Pain Crisis blog by Alexander DeLuca. You may find ways to advocate so you and others with chronic pain may see some change.
Here is the link in case the above one is broken:
http://doctordeluca.com/wordpress/
July 17, 2009
Thanks Christian.
Anon, for sure check out War on Docs/Pain Crisis for a lot of good background on our terrible predicament.
For support, for a highly educated and experienced community of chronic pain patients, I highly recommend the Chronic Pain Forums of the Pain Relief Network - you will discover that you are amongst Friends. That URL:
http://painreliefnetwork.org/forums/
hope this helps,
..alex...
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