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By Stanley Caroff MD, Stephan Mann MD, Gregg Gorton MD, E. Cabrina Campbell MD, and Rajnish Mago, MD
Dr. Caroff is Emeritus Professor of Psychiatry at the Perelman School of Medicine of the University of Pennsylvania. Click HERE for his bio.
Dr. Mann is in private practice in Harleysville, Pennsylvania. He is extensively published on topics including neuroleptic malignant syndrome, lethal catatonia, catatonia, etc.
Dr. Gorton is an Associate Professor of Clinical Psychiatry and Behavioral Medicine at the Lewis Katz School of Medicine, Temple University in Philadelphia, Pennsylvania.
Dr. Campbell is Associate Professor of Psychiatry and Residency Training Director at the Perelman School of Medicine, University of Pennsylvania in Philadelphia, Pennsylvania. She is also the Director of Acute Psychiatry at the Crescenz Veterans Affairs Medical Center in Philadelphia.
Dr. Mago is Editor-in-Chief of Simple and Practical Mental Health and Clinical Assistant Professor of Psychiatry at the Perelman School of Medicine, University of Pennsylvania in Philadelphia, Pennsylvania.
What is informed consent and why is it important?
Informed consent is an ongoing, interactive process to achieve agreement on a proposed course of treatment.
An informed consent discussion could strengthen an open, mutual therapeutic relationship, encourage patient ownership of and responsibility for treatment and minimize risks of adverse events and potential liability.
Whom to include
Inclusion of a family member or significant other in the discussion (with the patient’s permission) may help avoid misunderstandings and offers an opportunity to reinforce any benefits of medication that the patient may observe.
What should be discussed?
The discussion should include diagnoses and the potential risks and benefits of proposed treatments, alternative treatments, or of refusal of treatment.
When should informed consent about tardive dyskinesia be discussed?
The risk of TD should be discussed when antipsychotics are prescribed. This can present a challenge when trying to convince seriously-ill patients who lack insight into accepting treatment, and surveys show that prescribing clinicians often do not discuss the risk of tardive dyskinesia while prescribing an antipsychotic.
Clinical judgment should guide the what, when and how of presenting information about tardive dyskinesia in a manner that is likely to be helpful rather than harmful to patients. But, it has not been shown that the risk of nonadherence to medication increases if the risk of tardive dyskinesia is discussed. Patients do need to know about risks to reach an informed decision on treatment.
How should informed consent be documented?
Documentation is essential either in a written signed form or within a progress note. Policies of governments, institutions or insurance carriers should be consulted regarding this.
What exactly should be discussed?
The specific elements of a discussion about tardive dyskinesia may include:
• Very important – Benefits of and need for antipsychotic treatment if indicated over alternatives.
• Timing of the informed consent discussion — within 4 to 6 weeks or as soon as clinically feasible because tardive dyskinesia may develop within one month, allows time to recover from acute psychotic symptoms, cognitive dysfunction, and diminished competency or to decide on caregiver surrogacy.
• Incidence and risk factors – Up to 5% annually in adults, higher among the elderly and with more potent antipsychotics.
• Symptoms – in lay terms, e.g., abnormal movements, cramps, spasms, jerks, tics, etc. Most often but not exclusively involving orofacial region, vary in severity and impact.
• Self-monitoring of movements or any side effects reported promptly- some evidence that earlier diagnosis may allow for better chances of reversal. Inform and recruit caregivers in the monitoring process with permission.
• Steps to be taken to decrease risk – low-risk drugs and dosing, regular monitoring plan at visits, patient and caregiver participation.
• Masking/withdrawal effects – tardive dyskinesia may be unnoticed and appear only when doses or meds are changed or stopped.
• Tardive dyskinesia may be irreversible – why early identification is important.
• Treatment options if tardive dyskinesia occurs – including dosing changes or discontinuation of the antipsychotic, newly-approved treatments (VMAT2 inhibitors)
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