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Wednesday, April 1, 2009

FDA Shocks Hospice World: No More Roxanol

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UPDATE: THU 4/9/9 The FDA had a conference call and retracted the order to remove morphine 20mg/ml liquid. Please see this follow-up post here) I tried to come up with a great April Fool's joke to post here, but nothing seemed to be good enough. Until I heard a very good April Fool's prank (on Facebook and Twitter). Word was the FDA sent a letter to pharmaceutical companies demanding the halting of production of many non-FDA-approved concentrations of opioids, including the mainstay morphine 20mg/ml.

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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