Informed Consent Is Your Legal Right

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She was 32 and she looked tired.  She told me she had been abused in childhood.  A general physician whom I trust and who does a good job had sent her to see me, thinking she could be a little more relaxed and doing better with pharmacology.  We had not even talked about what kind.  This young woman was not sleeping well.  She made the interview easy as she already knew her diagnosis – post-traumatic stress disorder (PTSD).

Informed ConsentShe said the abuse had been both physical and sexual.  She still had an occasional dream or daytime thought about it.  She did her best to avoid the people who had done these horrible things to her.  Also she was “high strung.”  She confirmed that she tended to hyper-react to loud noises.  “I jump ten feet in the air,” she said.  So she had the three hallmarks of the diagnosis.  I am a woman with little faith in colleagues, so I always confirm the diagnosis.

I noticed, to my horror that the only medication she was receiving was Klonopin, also known as clonazepam, a half mg. twice daily.  Now she had been on nothing but this for many months.  I have a lot of troubles with drugs of this class: they are addictive, abusable, and at higher doses, which many people take sometimes, they can cause shakes or even seizures with withdrawal.  If she ever skipped a dose she would feel it.  Besides, they are central nervous system depressants, so they can actually cause someone go get more depressed.

These medications have not been shown to be helpful in post traumatic stress disorder to my knowledge.  Heaven knows they are used enough to “relax” folks and put them to sleep, even though their effectiveness may wane quite quickly.  I am confident that there are plenty of people (an old and conservative estimate is 20%) habituated to them in the Veterans Affairs medical system, where I have seen them used quite liberally. This is not what a young lady with post traumatic stress disorder needs.

I told the patient about Selective Serotonin Reuptake Inhibitors or “SSRIs,” which are by now considered to be “old staples” in the treatment of post traumatic stress disorder.  I even mentioned the name of Zoloft (sertraline), the first medication to receive FDA approval for the treatment of this illness. I was surprised by the patient’s response.

“I don’t want to take any mind altering drugs.” Ummm … Klonopin is a mind altering drug.  So is alcohol, which works in a very similar (in some ways identical) way in the brain.

I was shocked, but I launched into what I thought was a reasonable discussion of research, psychiatry, and how much better I thought I could help her feel.

“Don’t give me things I don’t want.”

Now I was starting to feel my blood boil.  This woman, who seemed angry at me although I had tried very hard not to be provocative, clearly had been hurt by someone or something in the past who was trying to, or who actually did, give a drug she did not like or want.

I took a deep breath and switched gears.  I apologized to her, but I had to ask her “dumb shrink questions” and assess her for competency and safety.  She told me she understood.

The process was rapidly completed. I went on to offer her things that would help her feel better, which was all I had ever wanted to do.  I told her she could refuse, as I had just then judged her competent to make her own decisions.  I explained “informed consent.”

Informed consent is not just for psychotropic drugs.  It is for any medical procedure.  She found relief when I empowered her, I think.

I told her everybody should know about informed consent.  I thought of a friend of mine, an intelligent woman, who had been told to take an experimental antibiotic and did not know — and told me she had not been told — that there were proven antibiotics, which her insurance would have paid for.

Anyone who is asked to go ahead with a medical procedure needs to be told the following facts.

1.  Their diagnosis.
2.  What the medication or procedure is supposed to accomplish.
3.  The benefits as well as the risks of the medication or procedure.
4.  The possible alternatives to the medication or procedure.
5.  The consequences of failing to treat the illness with any medication or procedure.

The best site for this on the net is one intended as a tutorial for medical students or students in residency training.

This whole question of informed consent is actually more complex than the above questions.

Often, there are printed documents to sign before a procedure — or in some places, even before accepting a prescription.  Sometimes there is a “one size fits all” consent form for accepting treatment, sometimes these papers are specific for specific drugs.

It is hard to tell everything in an informed consent, expecially in a bureaucracy that limits how much time can be spent with a patient. Most doctors try and make sure they discuss the most common side effects and complications, as well as the most severe.

Another complication is the capacity to give informed consent.  This is a frequent question for community and administrative psychiatrists, and those who deal with psychiatric law.

This patient had never been offered psychotherapy for her condition, something which could be quite helpful.  I arranged for her to be referred for same. I still could not convince her to try what I thought would be a less addictive and more effective pharmacology.  But I did find, and document, that she had the right to choose what she wanted within acceptable parameters

They can’t all agree with me.  I just try to be fair and square.

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Comments on Informed Consent Is Your Legal Right Leave a Comment

May 27, 2012

Velden @ 9:14 am #

I am an individual whose quality of life has been profoundly diminished by SSRI side effects that have persisted since discontinuing the medication fifteen years ago, and who was not informed of risks. Thus, I appreciate your attention to informed consent, to patient empowerment, and your committment to honoring your patients’ preferences even when those strike you as ill advised. Though your frustration is evident, I appreciate your awareness that informed consent is not about persuading a patient to your point of view. You strike me as earnest, patient-centered, and willing to be human.

I am wondering, what content do you think is necessary for patients to adequately understand risks, benefits and limits to knowledge about SSRIs? In the case of your patient with PTSD, I am aware that SSRI side effects may mimic symptoms of PTSD— i.e. SSRIs are often activating, disrupt sleep architecture and are associated with vivid dreams and nightmares. They may also diminish sexual interest or functioning, leading to withdrawal from intimacy and other partnership problems. They may pose more serious withdrawal problems than is generally acknowledged. (As I am sure you are aware, benzodiazapines were routinely co-administered to patients in SSRI approval studies to treat activation). I realize SSRIS are approved for PTSD, but most patients (particularly veterans) with PTSD are also taking multiple other psychotropic medications. Thus, how might you have gone about talking with this, or any patient with PTSD about what you see as risks and benefits of an SSRI, and how you would attempts to tease out the often ideosyncratic impact? I have seen many admonishments for good informed consent practices, but I have not yet found a written treatment of what that should look like– and I have searched exhaustively (that is how I found your blog).

June 5, 2012

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