Off-label prescribing is when a physician gives you a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than your condition. This practice is legal and common. In fact, one in five prescriptions written today are for off-label use.
—Agency for Healthcare Research and Quality
Psychotropic drugs are commonly used for children and adolescents to treat mental health disorders, yet many of these drugs are not FDA approved for use in these populations. Thus, their use is considered “off-label,” and it is often up to the best judgment of the prescribing clinician. As a PMHNP, you will need to apply the best available information and research on pharmacological treatments for children in order to safely and effectively treat child and adolescent patients. Sometimes this will come in the form of formal studies and approvals for drugs in children. Other times you may need to extrapolate from research or treatment guidelines on drugs in adults. Each individual patient case will need to be considered independently and each treatment considered from a risk assessment standpoint. What psychotherapeutic approach might be indicated as an initial treatment? What are the potential side effects of a particular drug?
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When a doctor prescribes you a prescription that the US Food and Drug Administration (FDA) has approved to treat a condition other than yours, this is known as off-label prescribing. This is a common and legal practice. Today, one out of every five medications is for an off-label usage.
—National Institutes of Health’s Agency for Healthcare Research and Quality
Psychotropic medicines are routinely used to treat mental health conditions in children and adolescents, however many of these drugs are not FDA approved for use in this population. As a result, their use is deemed “off-label,” and it is frequently up to the prescribing clinician’s best judgment. In order to safely and effectively treat children, you will need to apply the best available information and research on pharmacological therapies for children as a PMHNP.
