How to inform patients about the risks of antipsychotics

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Mass Effect

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I'm inheriting a patient who has schizoaffective d/o, has had multiple psych hospitalizations, and is currently stable (per records). This patient is not on an antipsychotic due to fear of TD. Previous psych's note states she informed the patient about the risks of antipsychotic meds, including TD and the patient has since refused, citing TD as the reason. It makes me wonder exactly what the psychiatrist said about TD and it made me wonder about my own spiel regarding the risks of this class of medication. So I'm curious, how do you tell patients about the risks without scaring them into refusing it?
 
You can just hand them a sheet that has all the risks of any drug you give..that should cover you from a liability perspective I would think
 
I discuss TD, acute EPS, Death by NMS, akithesia, metabolic/weight gain/diabetes at minimum for the class as a whole.
Its a patients right to refuse meds, laws are clear in the Good Ol' US of A.
Its a state's right to force meds if admitted involuntarily and so declared by the state as warranting them.
Your job is to inform and help educate on symptoms and treatment options, not to make them.
 
I agree with Sushirolls, I am very plain in my description of TD for patients. I also talk about how we will monitor for and address it if it emerges, trying to be accurate but reassuring / not alarmist. Most still go for it, but some do not and that is their right. I have worked with one woman who developed very severe TD on antipsychotics (prior to my meeting her) and was not warned about that beforehand, it seemed she felt very betrayed and I wouldn't want to be the psychiatrist responsible for that.
 
I discuss TD, acute EPS, Death by NMS, akithesia, metabolic/weight gain/diabetes at minimum for the class as a whole.
Its a patients right to refuse meds, laws are clear in the Good Ol' US of A.
Its a state's right to force meds if admitted involuntarily and so declared by the state as warranting them.
Your job is to inform and help educate on symptoms and treatment options, not to make them.

Well of course. That's why I'm asking. I inform them on the side effects and risks and allow them to make the decision. My question isn't about that. It's more about HOW you tell them as I note below in response to Bartelby

I also talk about how we will monitor for and address it if it emerges, trying to be accurate but reassuring / not alarmist.

This is what I mean. I find myself being very frank about the risks and so far, so good. I have had patients along the way refusing meds, but most don't. I'm just curious how you all talk about it so as to be reassuring/not alarmist.
 
I talk about movement side effects in general and how some could become irreversible, especially if used for decades. Discuss how meds exist for them now that work to varying degrees. I explain that it’s important to look at risks v benefits. We discuss the benefits. I also have a laminated page of the side effects of Tylenol for when patients are hesitant. Everything we do has risks. Even something as simple as Tylenol has many risks, but I bet you never read that side effect list. While I can’t predict individuals’ side effects, I wouldn’t recommend something that I don’t believe is in their best interest.
 
I'm straight forward, don't sugar coat and keep it matter of fact. Different clinicians, different delivery styles. I'm more blunt that some might critique. Conversely, I would counter critique those who are a bit more ambiguous. Part of what shapes my delivery are med side effects are a top 3 reason for psychiatry law suits. So, I intend to make sure folks are well informed even if it means they opt not to take a medicine.

As for the how to deliver the risk/benefit/alternative discussion to the patient I suggest you deliver it how you would want it presented to your family. I spend more time on these discussions, which is part of why I spend 90 minutes for consults and not usual 60, but that's my preference.
 
Tylenol is kind of an outlier. I'm wondering if it would be approved if it were introduced today. High risk and generally fairly ineffective for most of its indications.
 
. Part of what shapes my delivery are med side effects are a top 3 reason for psychiatry law suits. So, I intend to make sure folks are well informed even if it means they opt not to take a medicine.

Regardless of how anyone presents it, I’d advise having patients sign a med consent forms that have things like Tardive Dyskinesia spelled out clearly with related effects for liability purposes.

If I use the term tardive dyskinesia verbally, the patient’s eyes with gloss over. They won’t recall it. I use movement issues as everyone understands that and they know what to look for. Whether I use the term TD or not, there is no safety from liability as there is no proof. My paperwork with their signature confirms they were adequately informed from day 1.
 
Regardless of how anyone presents it, I’d advise having patients sign a med consent forms that have things like Tardive Dyskinesia spelled out clearly with related effects for liability purposes.

If I use the term tardive dyskinesia verbally, the patient’s eyes with gloss over. They won’t recall it. I use movement issues as everyone understands that and they know what to look for. Whether I use the term TD or not, there is no safety from liability as there is no proof. My paperwork with their signature confirms they were adequately informed from day 1.

cant you just hand them the fda sheet with all the side effects along with a brief explanation and call it a day?
 
cant you just hand them the fda sheet with all the side effects along with a brief explanation and call it a day?

That's a really good way to ensure that nobody wants to take these and convey the impression to the patient that you don't really care about them.

I always start with the really common side effects (fatigue, weight gain) and the general phenomenology most people report when taking these so they know what to expect. I emphasize that the weight gain is not magic and comes primarily through increased food consumption but that their appetite will likely increase noticeably; I also make sure they understand we are going to keep an eye on metabolic markers and weight etc. to catch diabetes before it really starts. I talk about dystonias and how we will treat them and what to do if it happens (knowing Benadryl is a reasonable option makes people much less freaked out about this). I talk about akathisia, emphasizing that they will definitely know it is happening if it does and that it will usually go away if we stop the medication in question. I introduce tardive last as something that is also rare but might happen in the long run. I am careful to say that most of what we know about predicting it is based on the days when we used much higher doses of these medications but it is still possible. Then I try to complete an AIMS if at all possible and tell them we are going to do this every 6/12 months as appropriate so that this doesn't sneak up on us. I emphasize that it usually does not happen overnight but worsens over time.

I tell them I can't predict the future but that if they were my kin taking this, here are the things I would be really worried about, and here are the things that are possible in principle but I would not be losing sleep about. I also make it clear that if they have these side effects and they are unacceptable we are going to try something different and I am not going to insist on staying a specific course.

So far the only people who decline to take them after I get done are the people who a) don't especially think they need to be seeing me anyway and b) have had horrific experiences with neuroleptics in the past and aren't quite ready to try it again. It's not that common at this point.
 
Why do you feel a signed consent is necessary over documentation in your note that you reviewed the R+B (including enumeration thereof)?

Yeah I understand this concern if you are obviously using a cut and paste template (seems fishy, did you really talk about all that?) but if you, you know, don't document the discussion via CTRL+V a separate signed consent seems excessive.
 
Liability is different depending on where you practice, but it should not be the guiding principle.

Always any treatment discussion about the risks should start with a solid understanding of the benefits. Tricky for a psychotic person, but in reality if they didn't have ambivalence about a treatment being important or an inkling to value your perspective, they'd never be open to treatment anyway. You at least have to have them hear you think it's important for them.

Beyond that, I don't have specific advise except to frame things that are possible like TD and metabolic risks within the structure of how you'll screen for them and take action should they develop.

But even then, depending on the scenario, it may be ethically justified to restrict informing someone of the risks. Unfortunately you can't predict the future with certainty. But if you do choose ever to keep information from a patient's hands, you need to document why and how you came to that decision.
 
Why do you feel a signed consent is necessary over documentation in your note that you reviewed the R+B (including enumeration thereof)?

EMR is checking boxes now. Paper charts can be the same. I can always say I did it, but in fact, never do informed consent. A patient could allege that I never provide informed consent. With a hand signed document with meds listed that specifically states I discussed the meds and side effects and patient had an opportunity to ask any and all questions, it is hard to argue that they weren’t informed.
 
EMR is checking boxes now. Paper charts can be the same. I can always say I did it, but in fact, never do informed consent. A patient could allege that I never provide informed consent. With a hand signed document with meds listed that specifically states I discussed the meds and side effects and patient had an opportunity to ask any and all questions, it is hard to argue that they weren’t informed.
So type some free text? If it's to the point where the credibility of a contemporaneous description of the risk/benefit conversation in a note is in question, why would anyone believe you didn't forge their signature as CYA?
 
I saw many attendings do that as a student so I was asking from a liability perspective so yes absolutely for real
Maybe do this—if you saw a provider and you asked them about side effects for a medication, and they simply handed you a piece of paper and called it a day, would you go back to that person? Or would you think, gosh this person sucks.

I know what I would think.
 
Maybe do this—if you saw a provider and you asked them about side effects for a medication, and they simply handed you a piece of paper and called it a day, would you go back to that person? Or would you think, gosh this person sucks.

I know what I would think.

I completely agree with you. I am telling you what I’ve seen on the inpatient service and asking purely from a liability perspective regarding the behavior of these psychiatrists that Ive seen. Most of my questions are based on things I’ve seen or hypotheticals, Iwould obviously not be acting in that way as personally I think it’s very inappropriate but I’m just reporting and reflecting on what I’ve seen.
 
As TD tends to be a side effect from long term typical anti-psychotics, I would try to convince the patient that the risks of this occurring need to be weighed up against the short term risks of poorly controlled psychosis. Not addressing the latter can result in relapse or prolonged episodes – possibly needing hospitalisations, a higher dose of medications for a longer duration which potentially increases the risks of TD and other side effects.
 
So type some free text? If it's to the point where the credibility of a contemporaneous description of the risk/benefit conversation in a note is in question, why would anyone believe you didn't forge their signature as CYA?

If it’s in the note you wrote, then legally you did it right? I mean in a lawsuit they have no evidence that you lied in the note..it’s your word vs the patient and you have written evidence so you don’t need a signature right?
 
If it’s in the note you wrote, then legally you did it right? I mean in a lawsuit they have no evidence that you lied in the note..it’s your word vs the patient and you have written evidence so you don’t need a signature right?

Nope. Attorneys are tricky. Just a sample idea below. Not saying it would be this phrasing.

Attorney: How many notes do you write in a day?
Merely: 15
Attorney: That’s more notes in 1 day than I drive home in a week. I bet you have accidentally made a wrong turn in your 20+ years of driving that involved turning towards home/work when you were supposed to be going somewhere else. Maybe when you had someone in the car, deep in a conversation.
Merely: Possibly, I don’t recall.
Attorney: Exactly. It’s just muscle memory. We don’t think about it. We just do it because we do it many times every week. Have you ever in your life made a mistake?
Merely: Yes, everyone..
Attorney: Let me stop you there. You admit to making mistakes, and you agree that muscles sometimes take action by memory even though you don’t consciously think about moving the muscle. Did you see your patient’s journal?
Merely: No
Attorney: on the day she saw you in clinic, she made a notation that she didn’t understand the side effects. You may have been busy doc or used big words. Physicians sometimes use big words right? Yes or no?
Merely: Yes
Attorney: Physicians can get behind too. Yes or no?
Merely: Yes

Obviously you would have an attorney too and other questions would be asked. Opposing counsel just got you to admit that you make mistakes and sometimes use medical terminology. The patient also has written evidence that she didn’t understand what you were talking about, but she blindly trusted you, the person that harmed her.

Sure this may not get opposing counsel a win. Now with a Patient signed document that states the risks, that patient understood everything, that he/she had the opportunity to ask any questions, and that the patient agreed that benefits outweigh risks - it’s hard to argue that it didn’t happen.
 
Nope. Attorneys are tricky. Just a sample idea below. Not saying it would be this phrasing.

Attorney: How many notes do you write in a day?
Merely: 15
Attorney: That’s more notes in 1 day than I drive home in a week. I bet you have accidentally made a wrong turn in your 20+ years of driving that involved turning towards home/work when you were supposed to be going somewhere else. Maybe when you had someone in the car, deep in a conversation.
Merely: Possibly, I don’t recall.
Attorney: Exactly. It’s just muscle memory. We don’t think about it. We just do it because we do it many times every week. Have you ever in your life made a mistake?
Merely: Yes, everyone..
Attorney: Let me stop you there. You admit to making mistakes, and you agree that muscles sometimes take action by memory even though you don’t consciously think about moving the muscle. Did you see your patient’s journal?
Merely: No
Attorney: on the day she saw you in clinic, she made a notation that she didn’t understand the side effects. You may have been busy doc or used big words. Physicians sometimes use big words right? Yes or no?
Merely: Yes
Attorney: Physicians can get behind too. Yes or no?
Merely: Yes

Obviously you would have an attorney too and other questions would be asked. Opposing counsel just got you to admit that you make mistakes and sometimes use medical terminology. The patient also has written evidence that she didn’t understand what you were talking about, but she blindly trusted you, the person that harmed her.

Sure this may not get opposing counsel a win. Now with a Patient signed document that states the risks, that patient understood everything, that he/she had the opportunity to ask any questions, and that the patient agreed that benefits outweigh risks - it’s hard to argue that it didn’t happen.

does this apply to even inpatient? I’ve never seen a doctor have someone sign something stating they understand the risks of Medication on the inpatient unit..but you do make an interesting point for sure
 
Nope. Attorneys are tricky. Just a sample idea below. Not saying it would be this phrasing.

Attorney: How many notes do you write in a day?
Merely: 15
Attorney: That’s more notes in 1 day than I drive home in a week. I bet you have accidentally made a wrong turn in your 20+ years of driving that involved turning towards home/work when you were supposed to be going somewhere else. Maybe when you had someone in the car, deep in a conversation.
Merely: Possibly, I don’t recall.
Attorney: Exactly. It’s just muscle memory. We don’t think about it. We just do it because we do it many times every week. Have you ever in your life made a mistake?
Merely: Yes, everyone..
Attorney: Let me stop you there. You admit to making mistakes, and you agree that muscles sometimes take action by memory even though you don’t consciously think about moving the muscle. Did you see your patient’s journal?
Merely: No
Attorney: on the day she saw you in clinic, she made a notation that she didn’t understand the side effects. You may have been busy doc or used big words. Physicians sometimes use big words right? Yes or no?
Merely: Yes
Attorney: Physicians can get behind too. Yes or no?
Merely: Yes

Obviously you would have an attorney too and other questions would be asked. Opposing counsel just got you to admit that you make mistakes and sometimes use medical terminology. The patient also has written evidence that she didn’t understand what you were talking about, but she blindly trusted you, the person that harmed her.

Sure this may not get opposing counsel a win. Now with a Patient signed document that states the risks, that patient understood everything, that he/she had the opportunity to ask any questions, and that the patient agreed that benefits outweigh risks - it’s hard to argue that it didn’t happen.

This kind of chicanery is not defeated by a piece of signed boilerplate. Substitute the analogy of asking you how often you sign those software licensing agreements without reading them and the derivation of an equally convincing argument is trivial for the deviously-minded.

I don't think this signed form has anything other than totemic value honestly.
 
This kind of chicanery is not defeated by a piece of signed boilerplate. Substitute the analogy of asking you how often you sign those software licensing agreements without reading them and the derivation of an equally convincing argument is trivial for the deviously-minded.

I don't think this signed form has anything other than totemic value honestly.

So the attorney will argue that the patient is too stupid or lazy to read a 1 page sheet of paper with 14 point font? It is nothing like a multi-page licensing agreement with legal terminology.
 
does this apply to even inpatient? I’ve never seen a doctor have someone sign something stating they understand the risks of Medication on the inpatient unit..but you do make an interesting point for sure

I’ve always done it on inpatient or had nurses do it. With children, both me and a nurse even sign it saying a parental verbally agreed over the phone.
 
So the attorney will argue that the patient is too stupid or lazy to read a 1 page sheet of paper with 14 point font? It is nothing like a multi-page licensing agreement with legal terminology.

And charting is nothing like driving a car. So why do you feel it is a compelling analogy, exactly?
 
And charting is nothing like driving a car. So why do you feel it is a compelling analogy, exactly?

Compelling? The rubbish I create between patients can not be held against me.

With a family full of attorneys, I just follow recommendations. Documentation is certainly valuable and the more of it the better. At the same time, it’s best if releases, consents, etc are signed by patients.
 
Compelling? The rubbish I create between patients can not be held against me.

With a family full of attorneys, I just follow recommendations. Documentation is certainly valuable and the more of it the better. At the same time, it’s best if releases, consents, etc are signed by patients.

All I mean by that is that if we really get down to people just lying about what happened in the appointment a piece of paper will not save you any more than contemporaneous documentation. I was about to ask if you get specific written consents for all medications but then I remembered you are CAP and it is a different world.

I don't really think consents for every individual medication think would fly in the places I have worked so far with adults and requiring it only for antipsychotics specifically seems odd.
 
All I mean by that is that if we really get down to people just lying about what happened in the appointment a piece of paper will not save you any more than contemporaneous documentation. I was about to ask if you get specific written consents for all medications but then I remembered you are CAP and it is a different world.

I don't really think consents for every individual medication think would fly in the places I have worked so far with adults and requiring it only for antipsychotics specifically seems odd.

I do it for all medications. Same form. Parts of the form does not apply to certain meds. It’s not meant to be an exhaustive list of everything the patient should know. It is a summary of what happened for informed consent and mentions the more concerning risks (like TD). I’m not claiming that it is perfect, but it has been helpful at times.

One example:
I did an evaluation on a child. Textbook ADHD. Both parents present. Signed consent for Adderall. Everything seemed normal. 2 weeks later father calls and is quite agitated that I prescribed his child a stimulant. Claims I never made that clear (baloney). Threatens to sue and blast social media (no adverse event occurred). I offered to send him the signed consent form with the word “stimulant” circled, Adderall written in, and his signature on it. I worded it nicely. He backed down. Would anything legally have happened here? Unlikely, but just knowing that I have it is usually enough to prevent issues.
 
I don't really think consents for every individual medication think would fly in the places I have worked so far with adults and requiring it only for antipsychotics specifically seems odd.
In several states, patients are required to sign consent specifically for antipsychotic medications in the institutional setting and possibly in the outpatient setting. this is because historically antipsychotics have been regarded as an unspeakable evil above any other drug.
 
EMR is checking boxes now. Paper charts can be the same. I can always say I did it, but in fact, never do informed consent. A patient could allege that I never provide informed consent. With a hand signed document with meds listed that specifically states I discussed the meds and side effects and patient had an opportunity to ask any and all questions, it is hard to argue that they weren’t informed.

I mean a patient could also allege that I never did a physical exam or a mental status exam....or took a HPI...

I get that it was useful for your angry dad above but this seems like a huge pain in the butt for every medication prescribed. Do you just have sheets pre-populated for every possible med you could give someone?
 
In several states, patients are required to sign consent specifically for antipsychotic medications in the institutional setting and possibly in the outpatient setting. this is because historically antipsychotics have been regarded as an unspeakable evil above any other drug.

Huh, had no idea. That makes this behavior make a lot more sense.

PA doesn't do that, but it is a state where literally the only medical procedure your court-appointed guardian or durable medical POA can't consent to on your behalf is ECT.
 
I mean a patient could also allege that I never did a physical exam or a mental status exam....or took a HPI...

I get that it was useful for your angry dad above but this seems like a huge pain in the butt for every medication prescribed. Do you just have sheets pre-populated for every possible med you could give someone?

Patients allege that physicians skip the physical exam all the time, especially when protesting bills. They want the coding downgraded due to cost. It doesn’t usually effect psych, but if a physician misses something big, it’ll be brought up in court.

I use the same form for all meds. I pull it out, fill in a few blanks, and have the patient sign it. Probably takes 30 seconds while I ask them if they have any further questions.
 
Patients allege that physicians skip the physical exam all the time, especially when protesting bills. They want the coding downgraded due to cost. It doesn’t usually effect psych, but if a physician misses something big, it’ll be brought up in court.

I use the same form for all meds. I pull it out, fill in a few blanks, and have the patient sign it. Probably takes 30 seconds while I ask them if they have any further questions.

I have literally never heard of a patient claiming a physical exam that was performed did not happen from anyone I ever worked with. Maybe there's something in the water in Texas.

Unless you mean a situation where someone clearly used a dot phrase populating an extensive negative exam of every system under the sun that they document for everyone and can't possibly be doing in every appointment. But again, that's different.
 
I have literally never heard of a patient claiming a physical exam that was performed did not happen from anyone I ever worked with. Maybe there's something in the water in Texas.

Unless you mean a situation where someone clearly used a dot phrase populating an extensive negative exam of every system under the sun that they document for everyone and can't possibly be doing in every appointment. But again, that's different.

It’s usually one of the top complaints of hospitals in the billing department. Patients will claim a PE wasn’t done or that it was poorly done. These complaints are often ignored. Insurance companies get complaints about these bills. They poorly educate patients on what billing codes entail. Patients then complain that it wasn’t sufficient.

Usually the patient just lacks education or hasn’t reviewed the note. Think laceration to the hand. The PE is going to be mostly local to the skin/underlying tissue and bone. Patients will complain that no exam was done - in actuality the exam was mostly visual - the skin.

Some physicians move quickly and miss things. Documentation of CV will state RRR, no murmurs yet a murmur has been well documented elsewhere.

I’ve seen normal documentation of the abdomen by midlevels yet patient has a colostomy bag. Was it done? Who knows?
 
Have pt who I added bupropion 150 mg and switched from Abilify 20 mg to Vraylar 4.5 mg. Pt now says the meds caused her to have a car accident. At first she said it was bupropion that caused the car accident but not sure if in fact it could have been related to the vraylar if she started taking it as recommended. Pt is litigious and wanted to sue psychiatrist at hospital where she was last involuntarily commited.

Anyone run into issues with this before?
You could tell them that while some meds can impair driving you think it is highly unlikely that any of those meds would have impaired driving ability. However, if they really believe that to be the case, you will have to file a confidential morbidity report and have the DMV yank her license.
 
EMR is checking boxes now. Paper charts can be the same. I can always say I did it, but in fact, never do informed consent. A patient could allege that I never provide informed consent. With a hand signed document with meds listed that specifically states I discussed the meds and side effects and patient had an opportunity to ask any and all questions, it is hard to argue that they weren’t informed.
Does he said she said really hold up in court? Patient says you didn't inform, you say you did. Who's to say what really happened?
 
Does he said she said really hold up in court? Patient says you didn't inform, you say you did. Who's to say what really happened?
Certainly if it wasn't documented, it didn't happen
 
Nope. Attorneys are tricky. Just a sample idea below. Not saying it would be this phrasing.

Attorney: How many notes do you write in a day?
Merely: 15
Attorney: That’s more notes in 1 day than I drive home in a week. I bet you have accidentally made a wrong turn in your 20+ years of driving that involved turning towards home/work when you were supposed to be going somewhere else. Maybe when you had someone in the car, deep in a conversation.
Merely: Possibly, I don’t recall.
Attorney: Exactly. It’s just muscle memory. We don’t think about it. We just do it because we do it many times every week. Have you ever in your life made a mistake?
Merely: Yes, everyone..
Attorney: Let me stop you there. You admit to making mistakes, and you agree that muscles sometimes take action by memory even though you don’t consciously think about moving the muscle. Did you see your patient’s journal?
Merely: No
Attorney: on the day she saw you in clinic, she made a notation that she didn’t understand the side effects. You may have been busy doc or used big words. Physicians sometimes use big words right? Yes or no?
Merely: Yes
Attorney: Physicians can get behind too. Yes or no?
Merely: Yes

Obviously you would have an attorney too and other questions would be asked. Opposing counsel just got you to admit that you make mistakes and sometimes use medical terminology. The patient also has written evidence that she didn’t understand what you were talking about, but she blindly trusted you, the person that harmed her.

Sure this may not get opposing counsel a win. Now with a Patient signed document that states the risks, that patient understood everything, that he/she had the opportunity to ask any questions, and that the patient agreed that benefits outweigh risks - it’s hard to argue that it didn’t happen.
I am completely certain that if an attorney asked me those questions 1. My attorney would intervene 2. I wouldn't answer those odd and irrelevant questions 3. This bizarre and frank trickery wouldn't be accepted. The pseudologic could be applied to literally any action anyone has ever taken. Asking someone in court if they've ever had a normative experience in a car as a trick to discredit the validity of a legal document is clearly a move by an attorney that nobody would ever respect.
 
Certainly if it wasn't documented, it didn't happen

I've been told by forensics psychiatrists that's not necessarily true.

And conversely, does documentation automatically mean it happened?
 
I've been told by forensics psychiatrists that's not necessarily true.

And conversely, does documentation automatically mean it happened?
I’ve been really into watching medical depositions lately. They will certainly push the line not documented = didn’t happen, but of course it’s up to the jury to make a decision on that if case goes to trial
 
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