Informed Written Consent (IWC) Prior to the Administration of Psychotropic Drugs

By Massachusetts law, informed written consent (IWC) must be obtained before administering a psychotropic drug to a long-term care resident (nursing home or rest home resident).   Psychotropic drugs include antipsychotics, antidepressants, anti-anxiety medications, and sedatives.  These drugs affect brain function and work to change perception, mood, or consciousness to treat psychiatric conditions.

It’s important to note that the law also requires IWC before administering any drug used in the treatment of a psychiatric diagnosis or symptom to recognize that other drugs can be misused to sedate or subdue residents (e.g. anti-seizure drugs).

In most cases, the resident, or if the resident is incapacitated, the resident’s legal representative (e.g. health care proxy, guardian, etc.) provides consent or denial of the drug.  In certain situations regarding antipsychotic drugs, a court-approved treatment plan may be required.

Before giving consent, you should make sure the drug is the best possible choice based on information obtained from the prescribing physician.  To help with this decision, ask the prescribing physician the questions listed in the last section below: Important Questions to Ask Before Consenting to Psychotropic Drugs.

Click here to find out more about the IWC law [PDF]. This document includes protocols for implementing the law, a listing of psychotropic drugs (Appendix A), and approved IWC form (Attachment B).

Why informed written consent (IWC) is necessary for psychotropic drugs

Psychotropic drugs have positive outcomes when used as intended.  However, they have a devastating effect when misused as a chemical restraint to manage what are labeled as “inappropriate” behaviors.  Residents with dementia who are unable to communicate about pain from physical or emotional conditions can exhibit behaviors that are sometimes “managed” by antipsychotics but are really misunderstood “communications” of medical, emotional or other problems.

Antipsychotics, in particular, have many serious side effects that can lead to death, particularly for the elderly with dementia.  As a matter of fact, the FDA issued its strongest warning, called a ‘black box’ warning, against using any antipsychotic with this population because of the related high mortality rate.  Black box warning labels must be put on drugs that show evidence of severe and life-threatening risks. The warning looks exactly like you would imagine – a black box on the product packaging with text inside describing the serious side effects.  Serious side effects include strokes, heart attacks, diabetes, pneumonia, and dizziness that can lead to falls.  It’s important to note that in 2005, the FDA cautioned that there is no approved drug for the treatment of dementia-related psychosis.

And there is the danger of substituting antipsychotic medications with other psychotropic drugs to (still) create a chemical restraint that robs people of their identity and dignity and causes physical injury.

Ensuring that people have a voice in their own care is the most basic step to eliminate the misuse of these mind-altering drugs.

About Informed Written Consent

As previously stated, a Massachusetts nursing home must obtain IWC from the resident or appropriate party before administering a psychotropic drug, or any drug used in the treatment of a psychiatric diagnosis or symptom. Consent must be obtained with an approved IWC form (Attachment B as noted above) that is signed which includes:

• Why the drug is being administered

• The prescribed dose of the drug

• The known effects and side effects of the drug

Review of Attachment B and a new execution of this form must be done each time a new or renewed prescription falls outside a previously consented dosage range, or once a year, whichever is shorter.

These drugs can only be administered without IWC in the following two emergency situations:

• When the resident poses an imminent threat of harm to him/herself or others, and there is no other option to prevent that harm.

• To prevent the “immediate, substantial and irreversible deterioration of a serious” medical condition.

When there is an emergency, the facility is required to continue an evaluation of emergency need and obtain informed written consent as soon as practicable, but no later than three calendar days following the emergency administration.

Important Questions to Ask Before Consenting to Psychotropic Drugs

Below are some questions you or your loved one should ask the prescribing physician before giving consent for a psychotropic drug to be administered. These questions are not covered in the informed written consent form, so they can be very helpful in better informing your decision.

1. What specific, documented behaviors or symptoms prompt the need for a psychotropic drug? For example, “Are there delusions or is the resident simply agitated?”

2. Have all possible medical or environmental causes (e.g., pain, dehydration, infection, sleep disruptions) been ruled out?

3. Has a doctor recently physically examined the resident to determine the need for the drug?

4. What alternative treatments have been tried? Are other options available?

5. Has the US Food and Drug Administration (FDA) issued a black box warning for this drug? (see above section: Why Informed Written Consent is Necessary)

6. Will the resident start on the lowest possible dose of medication?  This is particularly important, since the consent form uses a “dosage range” which means any dose within that range can be administered without a new consent.  Since side effects can be serious, it’s prudent to begin with the lowest possible dose to minimize any reactions to the drug and to allow room for an increase that does not cause an over-drugging situation.

7. Is the proposed drug duplicating other current medications?

8. Will the proposed drug interact with any of the resident’s other medications? If so, how?

9. How will the resident’s response to the medication and possible side effects be monitored?

10. When and how often will the need for the drug be reassessed?

11. Is there a gradual dose reduction plan to terminate use of the drug?

It is important to note the nursing home should explain the resident’s right to accept or refuse the psychotropic drug, the right to revoke consent for any reason at any time, and any exceptions to this right in the emergency administration of the drug.

It also may be helpful to speak with someone who has experienced these “informed consent” decisions such as another nursing home resident’s family member.