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New informed consent forms in Ohio


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This also fails to address giving children psych drugs and benzos. I was first given valium as a young teen. I was on and off it over many years before the last stretch when I decided to quit forever because they weren't helping me.

In retrospect, they never provided any lasting therapeutic benefit.

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Once again, "Informed Consent" is a title the implies the desired outcome (Consent).  It it were in the patient's best interest, it would be an "Informed Refusal" form.  Of course that will never happen.

 

Think about the difference between "opt out" and "opt in" clauses in contracts and the implications each have and you will see what I mean.

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Hello All,

 

I've read through these posts several times. I'd like to ask a few questions. These are earnest questions. I don't know the answers and would like to understand people's perspectives. There are quite a few, so if you don't care to read through them, or if you just want to skim to a topic you have an interest in, I understand. Also, I used the word "you" a lot. Sometimes I think it's helpful to think about what I would do, but if we think only of what we as individuals would do in each case, we might miss out on the effects these kinds of forms might have on the populace as a whole. Maybe it would be helpful to think in terms of what would an average, reasonably bright person might do? But either method could be illuminating. Onward to the questions:

 

1) Are doctors currently being successfully sued for benzo prescribing? Can anyone point me/us to some information where doctors in sizable numbers are being successfully sued?

 

2) Has anyone successfully sued Pharma over a benzo? They are all out of patent now. Do we think Pharma is afraid of being sued? Would these forms do anything to prevent the millions of people who have already taken the drug from pursuing such an action?

 

3) Many doctors do not know the risks these drugs pose. Would these forms make those risks clearer to them? If that were they case, might that in itself create less prescribing?

 

4) Why is it assumed that these forms were written by doctors, with no input from patients? Does this sound like a document written by a drug manufacturer? They language is very strong, much stronger than I would expect from an unscrupulous doctor. Why is it assumed that if it were written by a doctor, or group of doctors, that they did so self-servingly? Are all doctors now immediately suspect and filled with evil intent? What about those who work for the Alliance? Or BIC? It would be helpful to know the provenance of this document. Who wrote it? Where did it ultimately originate?

 

5) It was suggested that people who are prescribed benzos are very often in moments of acute crisis, and therefor have a limited capacity to make informed choices. Is there any way to know how often this is the case? I guess one way would be to see what the majority of benzo prescribing is for. I assume they are not prescribed (on their own and out of an institutional setting) for psychosis. So, if many people are prescribed benzos for things like dry eyes, menopause, muscle pain, mild anxiety, trouble sleeping, etc., does that change the calculus on the usefulness of these documents and people's ability to give real consent?

 

6) People are asking if the doctor has to check off the informed consent boxes as well. Why do we think this would be necessary? Isn't the fact that the doctor is the professional providing the form for you to sign in and of itself an admission that the doctor is acknowledging the risks as they are outlined? If a doctor had you sign a form about potential risks, and then said that they didn't know or agree with the form, now that very clearly sounds to me like grounds for a lawsuit. Does anyone agree/disagree?

 

7) If we agree providing this form, and requiring it to be noted and signed, means the doctor was also aware of the risks, wouldn't that make them more responsible for treating bad outcomes? Just like someone who prescribed chemo drugs is responsible for managing their patient's symptoms?

 

8 ) Does Informed Refusal make sense grammatically for a form you would sign? Can you actually sign a form that refuses consent? What would be the point of signing it? Wouldn't you just not sign it? And not take the drug?

 

9) I'm not sure I understand the real-world importance of the semantic difference between Informed Consent and Informed Refusal. Is the problem that the idea of consent predetermines the outcome in a linguistically coercive way? I'd like to see if that were true of other areas of medicine where informed consent is used. If it's just a problem with the name, does that mean that the entire document is worthless, or just that it needs a better name?

 

10) The Patient Information Inserts I have for Klonopin and Valium do not contain all of this information, and certainly not in such stark writing. The risks are downplayed and hidden. They were written by the manufacturers. Does that matter?

 

11) Is there a difference when you receive this information before you agree to take the drug, make a plan with your doctor, have the prescription sent over, pick it up, pay for it, take it home, and then maybe or maybe not read the document? This requires you to read the document before any of that happens. Is it more likely you will not take the drug before you have expended all that effort, or after? Might you not entertain less dramatic alternatives first, knowing the risks? I.e. does the context of both the timing of your informed decision, the clarity of the document, and the fact that you must read it and are not allowed to just throw it away, make it more helpful?

 

12) Most people are prescribed these for short-term use, and some still suffer needlessly from withdrawal because they are not tapered well. If doctors are forced to hand out forms, and get their patients to sign them, saying that these drugs are potentially dangerous and can lead to dependency, would that not also mean more (not necessarily all, but more) doctors would be likely to look into how to safely taper them? Both for short term-users, and long-term users?

 

13) Do people believe that these forms must help all or even the majority of patients, or else they are worthless? If they led to a few thousand less people each year becoming dependent, wouldn't that still be a good thing?

 

14) There is no regulatory agency that has any interest dealing with this problem at the moment, certainly not the FDA, in the meantime, is this not a reasonable first step?

 

15) Does anyone think that signing these forms would make it more likely for people to take them? That seems highly unlikely, I haven't heard anyone make that claim. So if we grant that they will probably convince some doctors to not prescribe, and some patients to not consent...does that mean rejecting these forms mean we are willing to let more people take benzos so that we can sue our doctors? I'm not quite how to word that. It's about risk vs benefit of the forms; I know no-one here wants a single other person to go through this. But still, the question stands.

 

16) Shouldn't children have some say in informed consent? Should parents always have the right to medicate their children? Can children not refuse to be drugged? I understand if they are displaying severe psychosis, but again, that's not what these drugs are for. Perhaps that is a larger discussion for another day.

 

Thank you for indulging me. I'd be happy to hear people's responses to any or all of these questions. I think your answers would be clarifying for further discussion.

 

best,

quiet

 

 

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I think this is a positive step.....I believe a lot of these informed consent forms were put into place as a result of the people harmed bringing attention to the legislatures.  As Benzogirl stated, it's a good start.  It would be nice if they could include what "withdrawal" symptoms could look like and that up to 50% of people could experience these (or whatever the actual percentage is).  And that you can get said withdrawal symptoms even while taking the medication.  A lot of sites I have seen in the past talk about withdrawal symptoms as what you get when you STOP the drug.....don't even mention that you can get them while tapering down or while in tolerance.  I also like that they include the Z drugs b/c those had been assumed to be safe for so long and clearly, they are not.

 

Doctors ARE starting to pay attention.....my new doctor, who is wonderful and letting me taper at my own speed, just informed me today that the group she is in has just determined that they will no longer prescribe new patients (not already taking benzos) these medications.  I think this is a result of Medicaid in my state basically saying that benzos are not to be prescribed to patients for longer than 2 weeks unless they have seizure disorders or meet other (very few) conditions. 

 

My concern here, as always now, is that people are going to be ripped off, taken off way too fast.  Doctors need to be educated FIRST about how to properly get people off.....

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