Consumer Group Wants Simpler Patient Guides
21 CommentsBy Ed Silverman // July 29th, 2008 // 3:00 pm
The National Consumers League has petitioned the FDA to issue a guidance for a “combined and simplified document” for patients when they receive their prescription drugs. The move was made in response to what the NCL calls a “jumble” of paper in the form of package inserts and medication guides, among other things.
“It is very important that patients receive clear, useful information in plain language with their prescription drugs…Patients do not need to receive multiple and lengthy pieces of paper that are often redundant and may even contain conflicting information,” Sally Greenberg, who heads the NCL, in a statement. “The present jumble of documents ill-serves the patient who simply needs enough information to take a prescription drug safely and effectively.”
The multitude of documents delivered to patients in pharmacies arises from different FDA legal requirements or unwritten, informal interpretation of those requirements from offices within FDA, NCL complains, adding that some legal requirements were established long ago, and were intended to regulate communications directed to healthcare professionals and not directly to consumers.
The FDA-mandated documents for patient communications can be just “too much information,” says Greenberg. For example, a refill for antidepressants may include a Consumer Medication Information describing how to take the drug, its risks, and other info including risks from a med guide; a patient package insert from the manufacturer with a med guide; a med guide provided by the pharmacy; and labeling in the form of a sponsored message from the drugmaker.
“Many of these documents were never designed for nor intended to apply to the unique pharmacy environment,” says Greenberg. “The risks of patient confusion, conflict, redundancy, and pharmacy burden would be eliminated if FDA permitted a ‘single document solution’ for all patient-directed information disseminated in the pharmacy.”
NCL was joined by several national healthcare organizations in filing the petition, including the National Association of Chain Drug Stores, the National Community Pharmacists Association, the National Alliance for Hispanic Health, the National Alliance for Caregivers, the Food Marketing Institute, Healthcare Distribution Management Association, and Catalina Health Resource.
Gianna
this seems symptomatic of people really not wanting to know what the heck they’re taking.
I don’t know who these consumer groups are advocating for…not me…I never get enough information. If I’d gotten enough information I would never have ended up on the cocktail I was on.
Jaynesday
Gianna, good point but in my experience you really don’t come to that point until something bad happens to you. My family has been “enlightened” about drugs and devices after a painful loss. Those that don’t have that experience still trust the powers that be.
I think this is a good idea but I have some issues with it. First is that I don’t trust the FDA management to compile valid information. Second the basis for the simplified information will still be based on pre market information. We need to open up information on post market experiences of the consumer for a true understanding of drugs.
Justice in MI
Without jumping to conclusions….
The release from the NCL has almost identical language to FDA’s when it issued the “preemption preamble” which was a premable to a document that most of which concenred “simplified labeling.”
The point was that, if the PI is less “challenging,” than companies should not be liable for something that doesn’t suit simplicity.
What not keep the situation as it is - most pharmacies (I am familiar with Rite Aid) include a simplified overview, and if a pt. wants more they can either ask for, or google up, the full PI.
In the coming preemption environment, I believe it would serve consumers not at all to rely on a “simplified” label alone.
But the reality is that most people don’t look at any of this stuff, and I don’t believe they would be more likely to look if it were “simplified.”
Ideally, there would be studies about this. Anyone know of any?
Lisa Van S
Justice,
FDA held a two day hearing on this issue last June 12 & 13, their are studies and testimony that were presented, and the information, along with an FDA statement can be found on FDA’s website.
Pharmalot has also covered the Medication Guide issue.
Justice in MI
Thanks, Lisa. I was able to find threads here on Medication Guides related to particular drugs, but not the more general issue. Perhaps someone has that link.
Could not find FDA stuff on first pass, but will go back…
Justice in MI
Got it. For anyone interested, the FDA conference proceedings can be found at:
http://www.fda.gov/cder/meeting/medication_guides_200706.htm
One of the presenters was “our own” Lisa herself! Well done!
So what do you (Lisa) think about this petition, offered by NCL and what are mainly trade organizations and consulting firms on marekting/information distribution (”data management and data sharing,” etc.)
Nathan
I agree that this seems to have implications for preemption. If the “simpler” patient guide is mandated by the government, then can pharma be held liable when a consumer sues claiming lack of info? Who’s liable when a consumer gets injured due to a side effect noted on the doctor’s info but not on the simplified patient guide?
I think this demand for a simpler patient guide comes from the issue we’ve talked about a lot on this website: Is pharma including “laundry lists” of side effects on drug inserts in order to shield against lawsuits? If so, can the FDA limit the lists of side effects? If the FDA can mandate limits on listing side effects, then can pharma really be held liable when that same side effect appears?
It seems to me that a simpler patient guide works in favor of preemption.
AA
Jaynesday, I totally agree. As one who developed a hearing loss from Remeron, I can tell people until I am blue in the face that drugs can be ototoxic. But until it happens to you, it is hard for people to believe.
Also, if doctors refuse to acknowledge these types of side effects, how are you going to have an accurate listing? I was misdiagnosed as having meneires disease and in reading about the experiences of other people on this blog who suffered hearing loss from meds, they usually had the same experiences.
Sorry for being a cynic but I see this as one more wasted attempt that will cost alot of money and do absolutely nothing for people taking meds.
AA
Lisa Van S
Justice,
I am curious as to where they receive their funding from! Would love to see their patient list because it doesnt jive with testimony patients gave to FDA.
Justice in MI
Agree. The National Alliance for Hispanic Health appears to be significantly funded by Merck - there are a couple of Merck foundation logos at the center of their home page. Obviously, that doesn’t mean it isn’t a good organization. But it may be at least worth noting.
The data consulting groups promise both increased market share as well as better pt care - a “win-win” situation, as one of them says. Again, it’s a Rorschach how one decides to take this.
Re: Nathan’s point, I certainly follow the logic, but I haven’t found an instance in actuality - that is, when a warning or AE is listed defensively. If someone knows of some, I’m genuinely interested in hearing.
As I’ve looked through CDER documents concerning label negotiations, companies seem to be always fighting _not_ to include something. This is not only in the case of “famous” instances in which Merck fought against a CV warning in the Vioxx/Celebrex showdown. Still, in retrospect, I would guesstimate that Merck would have saved more than they lost if they’d put the warning on sooner.
So, as above, I am very interested in hearing about clear instances of “defensive overwarning” in the real world.
Justice in MI
One other pt. re: Nathan’s good post. The petition is explicitly _against_ the current situation in which pts do get simplified overviews, but can get the PI as well. That is the idea of the “one-document solution.”
The petition’s description of what pt’s currently receive (even though most don’t look at it) is described in what I would call “purple prose.” The petitioners seem so anxious to get rid of that potential info source that - in my view - they protest too much.
Way too much.
Nathan
JIM - I guess I misspoke. I’m not aware of cases where pharma intentionally lists side effects in order to avoid lawsuits. However, it appears that the FDA and consumer groups are unintentionally pushing us in this direction when they insist on listing every adverse event that may or may not be related to the drug. Pharma gladly complies because they don’t want to be sued. I’ve mentioned this in previous posts, but if you haven’t looked at it before, please glance at this web site of prescriber information for Aleve:
http://www.fda.gov/cder/foi/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf
Look at the list of side effects. Dozens and dozens and dozens. I would estimate well over 150 side effects lists – many very very serious. **This is a laundry list.** Why is it this way? This is an OTC pain medication commonly believed to be much safer than Vioxx. Based on reading this information would you really believe that this is safer than Vioxx? How is a consumer (or doctor) supposed to learn anything from this information? This is just a information overload and an example of the system gone amuck. Do you disagree?
Nathan
By the way, in case you don’t want to scroll through the above link — pages 9-17 list the side effects. Almost a continuous 8 page listing off every ailment common to man. This is a laundry list!! Why would the FDA even allow this kind of list? Either the list should be much, much shorter, or this shouldn’t be a marketed medication. Certainly not an OTC.
Justice in MI
I see the point, Nathan. Yet I must say that I myself would still prefer a more complete list to a less complete one, particularly if there is some indication of likelihood (percentages, etc.) as many labels have. That is pretty much what the new “highlights” section of the PI does.
I have related that I personally had an AE with a med that wasn’t listed anywhere on its label (and still isn’t). But it has been the subject of a case report article (not just my own case) in the Archives of Opthamology, with comment that there is a high likelihood that it was, indeed, caused by the med. (Occurred and disappeared through three retrials.)
Had that information been on the PI - for both myself and my doc - I would have both felt less “crazy” and unnecessary additional testing and consults would probably have been avoided.
So I guess I can’t agree with the idea of “too much” information if at least physicians know how to use it. OTC becomes the responsibility of the rest of us, but I’m still unclear that having less is more useful and more is not. The throw-away that “this is just to shield lawyers”, or some other CYA purpose, does a disservice to pts who might actually find their own experience listed, and, in consultation with their docs, make more informed choices about what the next best steps may be.
Quibbler
Nathan,
Perhaps it’s a quibble, but the insert you link to is for prescription strength naproxen, not Aleve.
In my brief search I didn’t find a full package insert for Aleve, but the warning info on the Aleve website is much less extensive than on the Rx insert you link to.
http://www.aleve.com/tablets.html
Lisa Van S
Justice,
Pharmalot has covered the Med Guide issue
http://www.pharmalot.com/2008/02/congressman-wants-probe-into-med-guides/
This issue was a hot item during the PDUFA Hearings. I would be more than happy to provide you with Pharma, Congressional,. FDA Chain Drug Stores, documents that are a part of a Congressional Investigation.
This Petition is a joke, and should not be taken seriously!!!
Check this out
http://www.pharmalot.com/2007/06/in-nj-a-fight-over-black-box-warnings/
Lisa Van S
Justice,
http://www.pharmalot.com/2007/10/fda-diluted-antidepressant-med-guide-us-rep/
Justice in MI
Thanks, Lisa. I am up to my neck in preemption to get too far into the Med Guide issues (although related), but it is all interesting.
What puzzles me a bit is the role of the NCL, not that I know anything about them. Certainly, if one _were_ (note hypothetical) trying to advance a position that was not solely about consumers, they would be a good wooden horse to hide inside. (To use a Troy metaphor.)
Re: Quibbler’s quibble, it raises the question for me of whether OTC inserts are governed by different labeling requirements. Does anyone know?
Justice in MI
Re: the petition not being taken seriously, it seems so much in tune with the current FDA’s agenda that I wonder if we shouldn’t take it seriously in that sense.
It is almost like the current FDA regime is petitioning itself.
Lisa Van S
Justice,
Dan Troy has trained FDA well,..Pretty spooky.
Justice in MI
My impression is that senior management there were not hard to “enlist.”
As in other contexts, FDA’s salvation will also depend on people there with more guts than average to speak out about how things actually “go down.”