“Written informed consent” means written consent voluntarily signed by a patient who is competent and who understands the terms of the consent, or by the patient’s legal guardian or the parent of a minor.
As part of the written informed consent process, the healthcare provider must specifically review and document the Black Box Warnings concerning suicide. In reviewing the Black Box Warning, the healthcare provider must provide the patient with a Health Insurance Portability and Accountability Act (HIPAA) release form. Both the healthcare provider and the patient will agree on who will be monitoring the patient for changes in behavior as specified in the Black Box Warning.
A “black box warning”, also known as a “boxed warning”, or a “black label warning” is the most serious medication warning required by the Food and Drug Administration. All antipsychotics and antidepressants along with many other psychotropic medications have a black box warning. It is named for the border surrounding the text of the warning that appears on the package insert, label, and other literature describing the medication.
University student healthcare centers in Florida and around the nation serve a unique population. For many students, it is the first time they are living away from home and making decisions on their own, including life changing health care decisions. Most students are an inexperienced healthcare consumer. Young people will naively trust the doctor to make the right decision for them. It is imperative these young people have all the facts before choosing to undergo psychotropic drug treatment.
Currently, student healthcare providers are not insuring the patient has been given the necessary information to make an informed decision concerning the use of a psychotropic drug.
Student healthcare centers ignore black box warnings for drugs and do not have a procedure set up a monitoring system to monitor the patient. Doctors expect the patient to self-monitor despite the fact that a black box warning is the most stringent warning a medication can receive.
The most basic rule about psychotropic drugs is that the patient, or a decision-maker authorized to make decisions on their behalf, must consent to their use, after being informed of the possible risks, benefits, and alternatives.
Any drug capable of affecting the mind, emotions, and behavior.
A partial list of Commonly Prescribed Psychotropic Medications can be found here:
Because psychotropics can cause significant health problems, are less effective than non-pharmacologic options, and often represent a short-cut to taking care of a resident’s needs, their use is tightly proscribed by state and federal laws.
The Wisconsin Department of Health Services provides Written Informed Consent Forms for specific psychotropic drugs at the following website:
Before prescribing psychotropic medication, healthcare providers treating patients at student healthcare centers should provide the patient with written informed consent and document it. The written informed consent must include the following:
The State of Florida recognizes the importance of obtaining written informed consent for psychotropic drugs for Medicaid children and patients (F.S. 39.407 & F.S. 409.912). Before provides psychotropic medications to a child in the state custody, the prescribing physician shall attempt to obtain express and informed consent from the child’s parent or legal guardian.
The “acceptable standard of care” for prescribing psychotropic drugs must require written informed consent by an adult patient receiving treatment at the student healthcare center.
It is customary in Wisconsin, California and other states to obtain a signed consent for psychotropic drugs:
Wisconsin State Legislation 448.30 Informed consent. Any physician who treats a patient shall inform the patient about the availability of reasonable alternate medical modes of treatment and about the benefits and risks of these treatments. The reasonable physician standard is the standard for informing a patient under this section. The reasonable physician standard requires disclosure only of information that a reasonable physician in the same or a similar medical specialty would know and disclose under the circumstances. The physician's duty to inform the patient under this section does not require disclosure of:
(2) Detailed technical information that in all probability a patient would not understand.
(3) Risks apparent or known to the patient.
(4) Extremely remote possibilities that might falsely or detrimentally alarm the patient.
(5) Information in emergencies where failure to provide treatment would be more harmful to the patient than treatment.
(6) Information in cases where the patient is incapable of consenting.
(7) Information about alternate medical modes of treatment for any condition the physician has not included in his or her diagnosis at the time the physician informs the patient.
California Code of Regulations Title 9. Rehabilitative and Developmental Services Division 1. Department of Mental Health Chapter 4. Community Mental Health Services Under the Lanterman-Petris-Short Act
ARTICLE 5.5. VOLUNTARY PATIENTS' RIGHT TO REFUSE ANTIPSYCHOTIC MEDICATIONS
§ 850. Refusal of Antipsychotic Medications.
Every person admitted as a voluntary patient for psychiatric evaluation or treatment in any facility as listed in Section 860 of this subchapter has the right to refuse the administration of antipsychotic medications
§ 851. Informed Consent to Antipsychotic Medications.
A voluntary patient shall be treated with antipsychotic medications only after such person has been informed of his or her right to accept or refuse such medications and has consented to the administration of such medications. In order to make an informed decision, the patient must be provided with sufficient information by the physician prescribing such medications (in the patient's native language, if possible) which shall include the following:
(a) The nature of the patient's mental condition,
(b) The reasons for taking such medication, including the likelihood of improving or not improving without such medication, and that consent, once given, may be withdrawn at any time by stating such intention to any member of the treating staff,
(c) The reasonable alternative treatments available, if any,
(d) The type, range of frequency and amount (including use of PRN orders), method (oral or injection), and duration of taking the medications,
(e) The probable side effects of these drugs known to commonly occur, and any particular side effects likely to occur with the particular patient,
(f) The possible additional side effects which may occur to patients taking such medication beyond three months. The patient shall be advised that such side effects may include persistent involuntary movement of the face or mouth and might at times include similar movement of the hands and feet, and that these symptoms of tardive dyskinesia are potentially irreversible and may appear after medications have been discontinued.