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Posted: September 4th, 2023

Recommend one FDA-approved drug one off-label drug

After assessing and diagnosing a patient, PMHNPs must take into consideration special characteristics of the patient before determining an appropriate course of treatment. For pharmacological treatments that are not FDA-approved for a particular use or population, off-label use may be considered when the potential benefits could outweigh the risks.

In this Discussion, you will investigate a specific disorder and determine potential appropriate treatments for when it occurs in an older adult or pregnant woman.


Be sure to review the Learning Resources before completing this activity.
Click the weekly resources link to access the resources.


Choose one of the two following specific populations: either pregnant women or older adults. Then, select a specific disorder from the DSM-5-TR to use.
Use the Walden Library to research evidence-based treatments for your selected disorder in your selected population (either older adults or pregnant women). You will need to recommend one FDA-approved drug, one non-FDA-approved “off-label” drug, and one nonpharmacological intervention for treating the disorder in that population.
Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your chosen disorder in older adults or pregnant women.
Explain the risk assessment you would use to inform your treatment decision making. What are the risks and benefits of the FDA-approved medicine? What are the risks and benefits of the off-label drug?
Explain whether clinical practice guidelines exist for this disorder, and if so, use them to justify your recommendations. If not, explain what information you would need to take into consideration.
Support your reasoning with at least three current, credible scholarly resources, one each on the FDA-approved drug, the off-label, and a nonpharmacological intervention for the disorder.
American Psychiatric Association. (2016). The American Psychiatric Association practice guideline on the use of antipsychotics to treat agitation or psychosis in patients with dementiaLinks to an external site..

Agency for Healthcare Research and Quality. (2019). Maternal and fetal effects of mental health treatments in pregnant and breastfeeding women: A systematic review of pharmacological interventionsLinks to an external site..…
Hardy, L. T., & Reichenbacker, O. L. (2019). A practical guide to the use of psychotropic medications during pregnancy and lactationLinks to an external site.. Archives of Psychiatric Nursing, 33(3), 254–266.
National Library of Medicine. (2006–2020). Drugs and lactation databaseLinks to an external site. (LactMed).
The LactMed® database is a peer-reviewed, evidence-based resource on drugs that may be used by breastfeeding mothers. It includes possible effects on nursing infants and offers drug alternatives where possible.
Sadock, B. J., Sadock, V. A., & Ruiz, P. (2015). Kaplan & Sadock’s synopsis of psychiatry (11th ed.). Wolters Kluwer.
Chapter 27, “Psychiatry and Reproductive Medicine”
Chapter 33, “Geriatric Psychiatry”
Stewart, J. G., & DeNisco, S. M. (2019). Role development for the nurse practitioner (2nd ed.). Jones & Bartlett Learning.
Chapter 3, “Vulnerable Populations”
Chapter 4, “Mental Health and Primary Care: A Critical Intersection”
Chapter 5, “Cultural Sensitivity and Global Health”
American Psychiatric Association. (2020). Geriatric telepsychiatryLinks to an external site. [Video].…

As an AI language model, I do not have personal experiences and cannot diagnose or treat patients. However, I can provide general information based on research for educational purposes.

For this assignment, I have chosen the disorder Major Depressive Disorder (MDD) from the DSM-5-TR and the specific population of pregnant women.

FDA-approved Drug: Sertraline
Sertraline is an FDA-approved drug that can be used to treat MDD in pregnant women. It is a selective serotonin reuptake inhibitor (SSRI) that works by increasing the levels of serotonin in the brain. Sertraline has been shown to be effective and safe for treating MDD during pregnancy, as it does not seem to increase the risk of major malformations, neonatal behavioral syndrome, or neonatal mortality. However, there is a small risk of persistent pulmonary hypertension of the newborn (PPHN) associated with sertraline use during late pregnancy.

Off-Label Drug: Bupropion
Bupropion is a non-FDA approved drug for treating MDD in pregnant women. It is an atypical antidepressant that works by inhibiting the reuptake of dopamine and norepinephrine in the brain. Although it is not approved for use during pregnancy, some studies have shown that bupropion is effective and safe for treating MDD in pregnant women. However, more research is needed to confirm its safety during pregnancy.

Nonpharmacological Intervention: Psychotherapy
Psychotherapy, such as cognitive-behavioral therapy (CBT), can be an effective treatment for MDD in pregnant women. It involves talking with a therapist to identify and change negative thoughts and behaviors that may be contributing to depression. Psychotherapy has been shown to be effective and safe during pregnancy and has the added benefit of not exposing the fetus to any potential risks associated with medication use.

Risk Assessment:
The decision to use medication for treating MDD in pregnant women requires a careful risk assessment, weighing the potential benefits of treatment against the potential risks to the fetus. Sertraline is generally considered safe for use during pregnancy, but there is a small risk of PPHN associated with its use during late pregnancy. Bupropion is not approved for use during pregnancy, but some studies have shown it to be effective and safe. However, more research is needed to confirm its safety during pregnancy. Psychotherapy is a safe and effective treatment option for MDD in pregnant women, with no risks to the fetus.

Clinical Practice Guidelines:
The American Psychiatric Association (APA) has published practice guidelines for the treatment of MDD in pregnant women. These guidelines recommend the use of SSRIs, such as sertraline, as first-line treatment for MDD in pregnant women, but also acknowledge the potential risks associated with their use. The guidelines recommend considering nonpharmacological treatments, such as psychotherapy, as an alternative or adjunct to medication. While bupropion is not FDA-approved for use during pregnancy, the APA guidelines suggest that it may be considered as an alternative treatment for MDD in pregnant women who do not respond to or cannot tolerate SSRIs.

American Psychiatric Association. (2010). Practice guideline for the treatment of patients with major depressive disorder (3rd ed.).

Berard, A., Zhao, J. P., Sheehy, O., & Koren, G. (2017). The choice of antidepressants in primary care: Is safety an issue? PloS one, 12(6), e0178399.

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