Physicians may be sued for medical negligence based on a lack of informed consent if they prescribe medication without providing the patient with sufficient information to make an informed decision about whether to use the drug. Informed consent discussions may be particularly important when prescribing psychotropic medications because such medications may have extreme physical and psychological side effects. Side effects may include nausea, vomiting, weight gain, sleepiness, heart attack and/or stroke. Patients may also develop painful and sometimes irreversible disorders such as tardive dyskinesia, or experience suicidal ideation, hallucination or panic attacks. Patients may also begin to act aggressively, violently and/or impulsively due to their medication intake. There are a number of techniques that physicians can use to mitigate malpractice risk that may stem from the prescription of psychotropic medications and any side effects that may be endured.
It is important for physicians to stay up to date with prescribing information so that they can engage in effective informed consent discussions. Physicians can refer to guidelines from the Food and Drug Administration (FDA), American Medical Association (AMA), American Psychological Association (APA) and Physicians’ Desk Reference (PDR) to inform their patients about psychotropic medication options that may be prescribed. Physicians may consider using electronic prescribing software that provides alerts about potential problems and updates about new warnings as they are issued. Specialists and/or manufacturers may also be consulted if warnings are vague or otherwise unclear. These means can assist physicians in being prepared to help their patients make informed decisions after being provided with medication options and knowledge about potential side effects. Additionally, the guidelines are recommended from a legal standpoint because they may be used as evidence that prescriptions were issued in compliance with the standard of care if a lawsuit is brought.
More specifically, before prescribing new psychotropic medications, physicians should inquire about patients’ current medications and vitamin supplements to prevent adverse drug interactions. Blood testing may be required before beginning a new medication, as well. Physicians should document patient charts with all details regarding discussions about medication alternatives including any reasons for recommending one medication over another. Physicians should also document that all questions asked were answered, clearance information based on blood testing results, and patient preferences and reasoning upon providing consent. Obtaining patient consent in writing can be beneficial, too. All such documentation can be critical evidence of a patient’s well-reasoned and informed choice if a malpractice lawsuit is brought based on alleged lack of informed consent after an adverse complication or result occurs.
Physicians may further limit malpractice risk associated with prescribing psychotropic medications by monitoring patient progress. In this regard, patients should be informed that finding the “right” medication could require trial and error. Symptom relief may be affected by dosage or require patience in terms of experiencing the medication effects because some medications can take an extended period of time (often four to six weeks) to reach therapeutic levels. Medications may also be effective for a while but then symptoms may return and patients may require physician assistance to properly adjust and/or wean off medications. Thus, physicians should periodically monitor patient courses via physical presentation and/or blood work to facilitate effective medication treatment. More specifically, physicians should document the onset of medication side effects as well as any reactionary measures taken to prevent, for instance, patients from acting on suicidal or violent thoughts, which may then be sources of malpractice based on negligence and a lack of informed consent.
Documentation of physician adherence with these practices when prescribing psychotropic medication may be helpful in procuring a successful defense at trial as it may serve as evidence that the prescribing physician conformed with the standard of care.
Laurie A. Annunziato, Partner, and Michelle A. Frankel, Associate, are attorneys at Martin Clearwater & Bell LLP where they focus their practice on the defense of medical malpractice matters. For more information, visit mcblaw.com.